FDA Adverse Event
Injury
Summary report: N
CRYSTALENS ACCOMMDATING IOL
MDR report key: 4081101
·
Received August 29, 2014
Report
- Report Number
- 2031924-2014-00222
- Event Type
- Injury
- Date Received
- August 29, 2014
- Date of Event
- July 28, 2014
- Report Date
- August 1, 2014
- Manufacturer
- BAUSCH + LOMB
- Product Code
- NAA
- PMA / PMN Number
- P030002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT PRESENTED WITH "Z-SYNDROME." APPROXIMATELY 6 WEEKS POST IMPLANTATION, THE LENS WAS REPOSITIONED. TWO DAYS AFTER THE FIRST LENS REPOSITION, THE LENS WAS REPOSITIONED A SECOND TIME. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NO ADDITIONAL INFO HAS BEEN RECEIVED BY BAUSCH + LOMB TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 527638 | CRYSTALENS ACCOMMDATING IOL | LENS, INTRAOCULAR, ACCOMODATIVE | NAA | BAUSCH + LOMB | AT50AO | 7368018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |